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From YouTube: Bringing Trust and Privacy-Preserving Smart Contracts to Clinical Tri... Andrew Weiss & Bruno Vavala
Description
Bringing Trust and Privacy-Preserving Smart Contracts to Clinical Trials in Healthcare - Andrew Weiss, UMBC (in partnership with Softhread) & Bruno Vavala, Intel
The Healthcare ecosystem is undergoing a digital transformation to improve efficiency and costs. However, the transition from paper forms to PDFs, and from mail to email, still leaves many regulatory compliance aspects prone to human error. This is often the case with multi-site research clinical trials, which are subject to antiquated, costly and centralized data management processes. Each site is responsible for obtaining informed consent from participants, but problems associated with data integrity and conformance to the study’s guidelines can arise. Softhread will discuss how blockchain can be used in multi-site clinical trials to address existing security challenges and streamline information sharing. Also, with IBM and Intel, it will showcase a platform based on Fabric Private Chaincode, that preserves smart contract transaction confidentiality in hybrid cloud deployments.
To learn more about Hyperledger, the open source community focused on developing a suite of stable frameworks, tools and libraries for enterprise-grade blockchain deployments. Which serves as a neutral home for various distributed ledger frameworks including Hyperledger Fabric, Sawtooth, Indy, as well as tools like Hyperledger Caliper and libraries like Hyperledger Ursa click here: https://www.hyperledger.org/
Sessions Details & Slides (if available)- https://sched.co/j3ck
Access All Sessions: https://events.linuxfoundation.org/hyperledger-global-forum/program/schedule/
----
Hyperledger – Open Source Blockchain Technologies
Hyperledger is an open source community focused on developing a suite of stable frameworks, tools and libraries for enterprise-grade blockchain deployments.
It serves as a neutral home for various distributed ledger frameworks including Hyperledger Besu, Fabric, Sawtooth, Indy, as well as tools like Hyperledger Avalon, Cactus and libraries like Hyperledger Aries, Ursa. Learn more about Hyperledger projects: https://www.hyperledger.org/use
Case Studies: https://www.hyperledger.org/learn/case-studies
Training & Certification: https://www.hyperledger.org/learn/training
Tutorials: https://www.hyperledger.org/use/tutorials
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Follow-us on Twitter @Hyperledger
Learn about Hyperledger Membership: https://www.hyperledger.org/about/join
#Hyperledger #HyperledgerGlobalForum2021 #Blockchain
B
Awesome
well
hello,
everyone
good
morning,
good
afternoon,
good
evening,
wherever
you
are
in
the
world.
Thank
you
for
joining
our
talk
today.
My
name
is
andrew
weiss.
I'm
the
lead
architect
working
with
the
university
of
maryland
baltimore
county
in
partnership
with
softred,
and
I
want
to
introduce
you
to
bruno
as
well.
B
B
Trials
can
be
sponsored
by
various
organizations,
pharmaceutical
companies
and
other
health
care
entities,
but
they
can
really
only
be
initiated
after
they've,
been
approved
by
an
applicable
authority
or
committee
such
as
that
of
an
institutional
review
board
and
if
you've
participated
in
a
clinical
trial.
Maybe,
as
a
patient
you'll
be
aware
of
the
fact
that
you
have
to
give
consent
to
actually
participate
in
that
trial
or
inform
consent,
and
that's
for
the
disclosure
of
your
data
or
agreeing
to
the
trial
parameters
from
a
safety
perspective
and
when
you've
released
consent
for
the
clinical
trial.
B
You're,
then
you're
going
to
be
working
with
clinicians
and
researchers
working
alongside
those
clinicians
and
other
experimenters
that
are
going
to
be
collecting
data
from
that
clinical
trial
to
conduct
research
and
experiments,
and
typically
those
researchers
are
going
to
come
from
different
hospital
networks
or
networks
of
universities
and
so
forth.
If
you
want
to
go
next
slide.
B
B
Ultimately,
here,
of
course,
regulatory
bodies
and
regulations
and
processes
to
take
the
flow
of
these
clinical
trials
and
regulatory
bodies
such
as
here
in
the
us,
the
u.s
food
and
drug
administration
ultimately
set
the
standards
to
which
these
trials
have
to
be
compliant
and
any
point
in
time.
These
trials
can
be
audited
and,
furthermore,
you're
going
to
potentially
have
multiple
institutions
that
are
involved
in
trial.
B
So,
ultimately,
at
the
end
of
the
day,
really
safety
is
key
in
paramount
to
clinical
trials
and
it's
really
a
shared
responsibility
between
the
sponsoring
entity,
the
investigators,
the
institutional
review
boards
and,
in
many
cases,
the
regulatory
authorities,
such
as
the
fda,
for
which
these
drugs
devices
and
other
components
are
being
sold.
You
go
to
the
next
slide
bruno
but,
of
course,
related
to
clinical
trials.
B
Furthermore,
data
collection,
of
course,
is
key,
but
being
able
to
share
that
data
and
manage
that
data
securely
and
in
a
privacy
preserving
fashion
without
compromising
these
assets
are,
is
very
difficult
in
a
multi-site
clinical
trial
with
decentralized
systems.
You
know,
unless
you
give
these
other
institutions
access
to
those
systems
and
there's
parameters
that
get
that
access.
It's
very
difficult
to
share
that
data
and
then,
of
course,
compliance
makes
this
even
more
challenging
in
terms
of
adhering
to
the
critical
security
controls
that
are
forced
within
these
systems.
Today
you
go
to
the
next
slide.
B
Other
challenges
related
to
the
actual
conform
consenting
process
for
patients
themselves,
while
patients
are
signing
a
document
allowing
for
their
data
to
be
shared
in
a
clinical
trial.
These
documents
are
merely
point-in-time
documents,
whether
they're
paper-based
or
electronic,
based
and
oftentimes.
The
document
text
is
very
high
level
and
doesn't
allow
for
the
granularity
that
you
could
potentially
allow
for,
such
as
being
able
to
control
which
data
fields
and
which
elements
and
patient
information
is
being
shared
in
that
trial.
B
This
approach
really
gives
subjects
more
control
over
the
consenting
process
and
the
granularity
to
which
they're
willing
to
share
their
information
and
enables
ultimately
more
secure
multi-party
information,
sharing
all
powered
by
the
intrinsic
properties
of
distributed,
ledger
technology
and
the
blockchain
at
its
core.
You
go
the
next
slide
bruno,
so
the
sequence
flow
is
as
such
at
a
high
level.
Let's
you.
Let's
say
you
have
tom
who's
with
a
sponsoring
entity.
That's
looking
to
start
a
new
study
tom
is
going
to
put
together
the
requisite
study,
materials
and
consent
proposal
templates.
B
A
Now
we
acknowledge
that,
with
the
hyperledger
fabric
you
can
achieve.
Basically,
all
of
them
since
hyperledger
fabric
or
similar
frameworks
would
provide
trust
decentralizations
for
letting
multiple
institutions
cooperate.
It
still
allows
to
audit
operations
that
are
performed
on
the
on
the
blockchain,
and
it
has
several.
It
has
some
means
for
identity
management
and
data
protection.
A
Now
a
question
that
comes
up
is
by
using
a
framework
like
this:
do
we
make
any
progress
on
on
privacy
for
the
subjects
that
are
involved
now
to
answer
this
question?
It's
useful
to
look
at
the
scenario
before
and
after
using
this
framework
now
before
the
subjects
used
to
give
consent
to
the
to
the
irb
or
to
the
institutions
managing
the
trial,
and
then
they
would
provide
the
data
to
experimenters
and
investigators.
A
Therefore,
they
would
have
to
completely
trust
that
these
investigators
would
do
the
right
thing
and
always
follow
the
protocol
approved
for
the
trial
now
using
a
framework
like
fabric.
Well,
we
can
automate
the
consent,
form
gathering
and
the
approval
of
trials,
but
still
the
data
would
be
sent
directly
to
investigators
and
and
experimenters,
so
the
subjects
would
have
to
fully
trust
them
that
they
follow
the
pro
the
protocols.
A
A
Now
we
have
a
solution
to
these
privacy
issues
and
that
involves
the
use
of
fabric
private
chain
code.
Now
we
introduced
fpc
last
year
at
the
appalachian
global
forum,
so
we'll
just
give
a
brief
overview
of
of
this
framework.
It
essentially
extends
hyperledger
fabric
by
providing
confidentiality
for
for
chain
codes.
So
what
happens?
Is
that
fpc
wraps
the
fabric
chain
code
or
smart
contract
inside
an
intellij
x,
enclave
that
takes
care
of
protecting
the
confidentiality
and
integrity
of
the
code
and
data
that
constitute
the
chain
code?
A
So,
with
this
mechanism,
we're
able
to
isolate
the
chain
code
from
the
peer
component
and
the
organization
that
owns
the
sphere
component
in
fabric
and
the
chain
code
is
able
to
preserve
some
keep
some
secrets.
Also
among
the
secrets,
we
can
have
some
cryptographic
keys,
which
we
use,
for
example,
to
encrypt
key
value,
pairs
or
data
that
is
stored
on
the
ledger,
and
thus
it
would
be
public.
A
Therefore,
fpc
still
works
as
fabric
does,
but
any
data
that
you
will
see
on
the
ledger
will
be
stored
in
encrypted
form
now.
Another
question
that
comes
up
is
that,
okay,
how
can
the
clients
communicate
with
this
chain
code,
making
sure
that
they
can
preserve
the
pr
the
confidentiality
of
their
data
right
when
they
send
it
to
the
chain
code?
Well,
the
answer
is
pretty
simple
and
it's
by
using
hardware
based
attestation.
A
A
A
Now
with
the
fpc
chain
code
in
the
middle,
then
the
the
subjects
would
not
provide
the
data
directly
to
investigators
and
experimenters,
but
rather
to
the
pc
chain
code
itself,
because
it's
able
to
preserve
the
confidentiality
of
the
subject
data
at
the
same
time
before
we
had
that
the
irb
of
the
institution
would
delegate
would
give
full
trust
to
the
investigator
to
conduct.
The
study
and
investigator
would
be
responsible
in
this
case.
A
So
what
would
happen
in
this
case
is
that
the
investigator
would
not
be
able
to
delegate
directly
the
experimenter
to
do
something
because
experimenter
now
or
the
investigator
they
don't
have
access
to
the
subject
data.
Instead,
they
all
have
to
go
through
the
fpc
chain
code
in
order
to
perform
the
required
approvals
and
get
the
data
for
the
experiments.
A
So
the
investigator
would
delegate
any
tasks
through
the
fpc
chain
code.
The
office
in
general
could
check
that
the
trial
is
approved,
that
the
ex
that
the
investigator
gave
approvals
for
a
specific,
specific
experiment
and
if
the
experimenter
belongs
to
the
right
institution
and
is
using
the
right
tools.
For
example,
here
we
have
an
experiment,
application
inside
another
sjx
enclave.
C
A
Okay,
so
I
was
saying
we
prepared
this
demo
and
that
has
this
architecture
again,
you
know
the
part
is
involved
here
and
in
the
fabric
network.
Essentially,
there
are
two
chain
codes,
the
regular
one
that
takes
care
of
consent
and
trial
approval
and
the
fpc
chain
code,
which
will
take
care
of
managing
the
policies
related
to
data
protection
and
release
for
for
that
trial.
A
Now
to
be
clear,
the
part
related
to
consent,
trial
approval
and
so
the
regular
chain
code
that
belongs
to
the
solution
previously
described
by
andrew.
So
we
build
on
that,
but
this
will
not
be
part
of
of
this
demo.
Now
we
implemented
all
the
rest,
and
particularly
these
data
registration,
experiment,
approval
and
provisioning
phases.
A
After
that
the
experimenter
will
take
care
of
of
submitting
new
experiments
for
for
approval.
These
experiments
will
be
reviewed
and
possibly
approved
by
the
investigator,
and
only
at
that
point,
when
the
right
approvals
have
been
gathered
in
all
the
checks
in
the
experiment
approval
chain
could
pass,
then
that
fpc
chain
code
will
take
care
of
provisioning.
The
external
experimentation
service,
always
through
an
encrypted
channel,
to
preserve
the
confidentiality
of
the
subject
data
and
that
will
allow
the
experimenter
to
to
finally
run
the
experiment.
A
Of
course,
there
is
a
one
more
step
in
this
case
in
the
sense
that
the
data
sync,
the
experiment,
provisioning
phase
only
involves
decryption
keys,
so
the
experimentation
service
will
grab
the
encrypted
data
from
the
storage
service,
decrypt
that
and
finally
really
run
the
experiment.
That
would
give
the
final
result
to
the
experimenter.
A
So
this
is
a
joint
work
with
several
people
again
at
umbc
and
soft
thread,
ibm
and
and
intel
was
quite
a
bit
undertake,
and
here
we
have
a
short
video
of
the
demo.
The
reason
for
the
video,
the
reason
for
the
video
and
not
the
live
damage,
because,
as
you
can
see,
there
are
several
parties
involved
and
orchestrating
at
them
with
the
three
or
four
parties
and
8
to
10
web
services
would
be
quite
difficult.
A
So
here
we
have
our
ui
for
the
demo,
the
different
parties.
Sorry
about
that,
okay
data
provider,
experimental
investigator.
The
data
provider
in
this
case
is
our
subject
that
has
to
provide
the
data
for
the
experiment.
We
have
some
pdfs,
those
are
the
patient
data
forms.
We
will
see
those
in
detail
to
understand
what
kind
of
sensitive
data
the
patient
is
sending
for
the
experiment.
A
A
A
A
A
At
this
point,
the
data
is
ready
and
the
experimenter
now
wants
to
run
experiment
on
that
data.
Now
it's
worth
noticing
here
that
the
experiment
application
is
already
available
to
the
experimenter.
You
can
already
run
that,
however,
the
experimenter
does
not
have
access
to
the
subject
data.
It's
not
authorized
to
have
that.
So
what
he's
doing
here
is
to
is
submitting
a
new
experiment
for
approval,
and
here
the
experimenter
says.
Okay,
I
want
to
use
this
diagnose
python
function.
A
A
A
Okay,
so
the
experiment
gets
submitted
to
the
fpc
chain
code
and
at
this
point
the
experimenter
just
has
to
wait
for
approval
from
the
investigators.
In
this
case
three
investigators
who
are
notified
of
the
new
experiment,
and
they
can
go
ahead
and
review
that
in
reviewing
that
they
can
see
that
it's
an
experiment
about
presenting
diagnosis
of
nephritis
of
reynold,
pelvis
origin.
A
A
So
this
is
a
again
an
application
running
in
a
in
an
sgx
enclave,
so
it
can
be
verified
by
means
of
an
at
the
station
hardware,
based
at
the
station
by
the
fpc
chain
code,
and
in
particular
it
will
have
a
public
encryption
key
so
that
the
fcc
encode
can
send
the
data
or
the
decryption
key.
In
this
case
of
the
data
in
encrypted
form
directly
to
the
experiment,
application.
A
B
A
A
I
just
want
to
mention
that
these
enclaves
are
registered
on
the
blockchain,
so
people
parties
involved
can
always
verify
the
enclaves
that
are
available,
and
particularly
the
latest
security
tcp.
The
trusted
computing
base
that
they
that
they
used.
So
in
the
end
they
have
to
make
a
trust
decision,
whether
to
trust
that
or
not,
or
whether,
to
ask
for
an
upgrade.